BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONARMED

    MDR report key: 20238637 · Received September 17, 2024

    Report

    Report Number
    1282497-2024-00393
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    November 11, 2021
    Report Date
    September 17, 2024
    Manufacturer
    SONARMED, INC.
    Product Code
    OQU
    UDI-DI
    00851334007001
    PMA / PMN Number
    K193058
    Removal / Correction Number
    Z-0514-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H9: 806 NUMBER 3009923584-12212021-01-R THIS REPORT IS BEING SUBMITTED AS PART OF REMEDIATION ACTIVITIES ASSOCIATED WITH CAPA#643143, WHICH IS ADDRESSING MDR REPORTING GUIDANCE FROM FDAS 1995 PREAMBLE, WHICH ENSURES COMPLAINTS RELATED TO CORRECTIONS AND RECALLS WHICH WERE PREVIOUSLY REPORTED TO FDA UNDER 21 CFR 806 ARE NOT REPORTED AS MDRS; THIS IS NOT A NEW MALFUNCTION/EVENT. H3 DEVICE EVALUATION SUMMARY: REPORTABILITY REASSESSED BASED ON THE 806 REPORT SUBMITTED TO THE FDA. MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. IT WAS REPORTED THAT THIS SONARMED DEVICE HAD MUFFLED SPEAKER. THE PRODUCT SAMPLE OR ADDITIONAL SUPPORTING MATERIALS FROM THE ACCOUNT WAS NOT AVAILABLE FOR ANALYSIS. BASED ON THE EVIDENCE AVAILABLE THERE WAS NOT ENOUGH INFORMATION TO MAKE ANY DETERMINATION. WITHOUT THE SAMPLE A DETAILED INVESTIGATION COULD NOT BE PERFORMED, AND DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. BASED ON THE INFORMATION PROVIDED IN THE EVENT AND/OR OTHER SOURCE, THE SUSPECTED OR MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. FURTHER ACTION WAS NOT REQUIRED BECAUSE THE EVENT IS IN SCOPE FOR FCA Z-0514-2022. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SONARMED DEVICE HAD MUFFLED SPEAKER. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505827 SONARMED AIRWAY MONITORING SYSTEM OQU SONARMED, INC. AW-M0001 00851334007001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown